JP5806678B2 - System and apparatus for testing a blood glucose measurement engine - Google Patents

Description

  This specification relates generally to measurement engines for measuring blood glucose levels, and more particularly to systems and devices used for testing blood glucose measurement engines.

  Portable compact medical diagnostic devices are often used to measure the concentration of biologically significant components in body fluids, such as glucose concentration in the blood. A portable compact medical diagnostic device and its accessories can work together to measure the amount of glucose in the blood and can also be used by diabetics to monitor blood glucose at home, medical institutions, or elsewhere And can be used by medical personnel.

  Regular testing of blood glucose levels can be an important part of diabetes management for diabetics. Therefore, it is desirable to provide a medical diagnostic device such as a blood glucose measuring device that is portable and easy to use. For this reason, various portable blood glucose measuring devices have been introduced. In addition, modular blood that can be incorporated into host devices such as personal medical pumps (eg insulin pumps) and consumer electronics (eg mobile phones, smartphones, personal digital assistants, portable media players) Glucose measuring devices have been introduced. However, as such devices are constantly being modified, updated or improved, ensuring the compatibility and functionality of modular blood glucose measuring devices with such host devices presents unique challenges. To do.

  Accordingly, there is a need for alternative devices and methods for testing blood glucose measurement engines for use with host devices.

  In one embodiment, a system for testing a blood glucose measurement engine includes a host device emulator having a measurement engine port communicatively connected to a communication port and electrically connected to a power source. A diagnostic computer may be communicably connected to the communication port of the host device emulator. The diagnostic computer may include a processor and a memory comprising computer readable and executable instructions. When the blood glucose measurement engine is communicatively connected to the measurement engine port, the host device emulator facilitates communication of data signals, control signals, and diagnostic signals between the diagnostic computer and the blood glucose measurement engine. To simulate the connection to the host device. Computer readable and executable instructions for transmitting control and diagnostic signals to the blood glucose measurement engine, for receiving and analyzing data signals transmitted from the blood glucose measurement engine, and for the blood glucose measurement engine Can be executed by the processor to monitor the glucose measurement process performed by.

  In another embodiment, a host device emulator that facilitates communication between a blood glucose measurement engine and a diagnostic computer includes a power source and a communication port that is electrically connected to the power source and communicatively connectable to the diagnostic computer. It is out. The host device emulator also includes a measurement engine port communicatively connected to the communication port and electrically connected to at least one indicator and a power source. The measurement engine port can be communicably connected to a blood glucose measurement engine. The host device port is electrically connected to the power source and may be communicably connected to the measurement engine port and the communication port. The host device port can also be communicably connected to the host device, and the measurement engine port, host device port and communication port communicate data signals, control signals and diagnostic signals between the diagnostic computer and the blood glucose measurement engine. In order to facilitate communication of data signals and control signals between the host device and the blood glucose measurement engine, and data signals and control signals between the host device and the blood glucose measurement engine. Can be used to facilitate the use of a diagnostic computer for monitoring.

  These and additional features provided by the embodiments described herein will be more fully understood in conjunction with the drawings in light of the following detailed description.

  The embodiments described in the drawings are of descriptive and exemplary nature and are not intended to limit the invention specific features defined by the claims. The following detailed description of exemplary embodiments will be understood when read in conjunction with the following drawings, wherein like structure is indicated with like numerals and in which:

FIG. 1 schematically illustrates a system for testing a blood glucose measurement engine utilizing a host device emulator according to one or more embodiments shown and described herein. FIG. 6 schematically illustrates a measurement engine port of a host device emulator according to one or more embodiments shown and described herein. FIG. 2 schematically illustrates a communication port of a host device emulator according to one or more embodiments shown and described herein. FIG. 6 schematically illustrates a power supply circuit of a host device emulator according to one or more embodiments shown and described herein. FIG. 6 schematically illustrates a reset circuit of a host device emulator according to one or more embodiments shown and described herein. FIG. 6 schematically illustrates a wake request circuit of a host device emulator according to one or more embodiments shown and described herein. FIG. 6 schematically illustrates a programming port of a host device emulator according to one or more embodiments shown and described herein. FIG. 6 schematically illustrates an indicator circuit of a host device emulator according to one or more embodiments shown and described herein. FIG. 6 schematically illustrates a host device port of a host device emulator according to one or more embodiments shown and described herein. FIG. 6 schematically illustrates an expansion port of a host device emulator according to one or more embodiments shown and described herein. FIG. 6 schematically illustrates a component layout on the top surface of a host device emulator according to one or more embodiments shown and described herein. FIG. 6 schematically illustrates a component layout on the underside of a host device emulator according to one or more embodiments shown and described herein. FIG. 6 schematically illustrates conductive paths interconnecting various components on the top surface of a host device emulator according to one or more embodiments shown and described herein. FIG. 6 schematically illustrates conductive paths interconnecting various components on the underside of a host device emulator according to one or more embodiments shown and described herein.

  FIG. 1 generally illustrates one embodiment of a system for testing a blood glucose measurement engine. The system can include a host device emulator communicatively connected to a diagnostic computer. The host device emulator generally can include a power circuit, a measurement engine port, at least one indicator, and a communication port disposed on and interconnected to the printed circuit board. Various embodiments of systems and methods that utilize a host device emulator to test the host device emulator and blood glucose measurement engine will now be described in greater detail.

  The term “blood glucose measurement engine” as used herein refers to a device that can be used to analyze a sample of a biological material such as blood to determine the level of glucose contained in the biological material. In the embodiments described herein, the blood glucose measurement engine is a modular device that can be incorporated into or connected to a separate host device.

  The term “host device” as used herein refers to a portable electronic device that can be operatively connected to a blood glucose measurement engine. Host devices may include, without limitation, personal diabetes management devices ("PDM devices"), personal medical pumps (eg, insulin pumps), or mobile phones, smartphones, personal digital assistants, portable media players, etc. It may be a portable electronic device.

  With reference to FIG. 1, an embodiment of a system 100 for testing a blood glucose measurement engine is schematically shown. It should be understood that the solid arrows generally indicate the interconnectability of the various components of the system, including the various electronic components that are located on the host device emulator 102. It should also be understood that solid arrows indicate electrical signals such as control signals, diagnostic signals, and / or data signals that are transmitted between the various components of the system. For example, solid arrows between the diagnostic computer 180 and the communication port 130 indicate data signals, diagnostic signals and / or control signals transmitted between the diagnostic computer 180 and the communication port 130 of the host device emulator 102. May be. Furthermore, in the embodiments described herein, solid arrows indicate wired connections between various components. However, in other embodiments, solid arrows may indicate wireless connections between various components of the system. For example, diagnostic computer 180 and host device emulator 102 may be interconnected wirelessly using an RF transceiver or similar wireless communication device.

  Referring to FIG. 1, a functional block diagram illustrates one embodiment of a system for testing a blood glucose measurement engine. The system 100 includes a host device emulator 102 communicatively connected to a diagnostic computer 180. The host device emulator simulates the connection between the blood glucose measurement engine and the host device. The host device emulator 102 can generally include a communication port 130 to which a diagnostic computer 180 is communicatively connected. Similarly, communication port 130 may be communicatively connected to measurement engine port 110 and host device port. Measurement engine port 110 provides a blood glucose measurement engine such that data signals, control signals, and diagnostic signals can be communicated between the blood glucose measurement engine and a diagnostic computer 180 communicatively connected to the communication port. (Not shown) may be communicably connected. Similarly, the host device port 190 can communicate to the host device so that control signals and data signals can be communicated between the host device and a blood glucose measurement engine communicatively connected to the measurement engine port 110. May be connected.

  Diagnostic computer 180 includes a processor (not shown) and memory (not shown). In one embodiment, the memory is computer readable and executable for operation, testing, programming and / or reprogramming of a blood glucose measurement engine communicatively connected to the measurement engine port 110 of the host device emulator 102. Can be used to store instructions. The processor can be used to execute computer readable and executable instructions stored in the memory of diagnostic computer 180. In this embodiment, the diagnostic computer functions as a simulated host device that is operatively connected or otherwise incorporated with a blood glucose measurement engine. For example, a diagnostic computer may simulate the function of a host device such as a personal medical pump or similar portable electronic device, or a blood glucose test performed by a blood glucose measurement engine may otherwise be performed on the host device. The blood glucose measurement engine in a master / slave relationship with the blood glucose measurement engine so that the results of the blood glucose measurement initiated by the blood glucose measurement engine are received and utilized by the host device Control and / or manage Accordingly, a diagnostic computer, particularly a processor of the diagnostic computer, can be used to provide control and diagnostic signals to the blood glucose measurement engine via the communication port of the host device emulator 102, so that blood in the blood glucose measurement engine can be used. It should be understood that the glucose measurement is initiated and generally controls the operation of the blood glucose measurement engine.

  For example, computer readable and executable instructions stored in the memory of the diagnostic computer 180 can be used to send blood control signals to the blood glucose measurement engine via the host device emulator 102 by using a blood glucose measurement engine. It may be executed by the processor to initiate a glucose measurement. Alternatively, one or more diagnostic signals may be sent to the blood glucose measurement engine via the host device emulator. The diagnostic signal may be used to advance the blood glucose measurement engine step by step through each programmed instruction of the measurement process and pause the blood glucose measurement engine after each instruction is executed. .

  The diagnostic computer 180 can be used to receive data from the blood glucose measurement engine via the communication port 130 of the host device emulator 102 and store the data in memory for analysis. A memory operatively associated with the diagnostic computer 180 analyzes data received from the blood glucose measurement engine to determine the availability and functionality of the blood glucose measurement engine, and in the operation of the blood glucose measurement engine. To diagnose any errors, the computer may include instructions that can be read and executed, which can be executed by the processor. If the analytical data is obtained from blood glucose measurements made on standard glucose, such as a solution having a known glucose concentration, the memory of diagnostic computer 180 is obtained from blood glucose measurements made on standard glucose. Computer readable and executable instructions that may be executed by the processor to calibrate the blood glucose measurement engine based on the data may also be included.

  In another embodiment, the memory of the diagnostic computer 180 is between the host device connected to the host device port 190 of the host device emulator 102 and the blood glucose measurement engine connected to the measurement engine port 110 of the host device emulator 102. Computer readable and executable instructions for monitoring transmitted signals may be included, and these instructions may be executed by the processor of diagnostic computer 180. For example, control signals and data signals transmitted between the host device and the blood glucose measurement engine are also transmitted to the diagnostic computer 180 via the communication port 130 of the host device emulator 102. The diagnostic computer 180 can be used to record control signals and data signals in memory and / or display them in real time. The diagnostic computer memory may also include computer readable and executable instructions for analyzing control and data signals transmitted between the blood glucose measurement engine and the host device.

  Referring now to FIGS. 1-10, FIGS. 2-10 illustrate various electronic components and circuits that make up the functional blocks of the system of FIG. 1, and more particularly, various electronic components that comprise the host device 102. An embodiment is shown schematically. 2-10 also illustrate circuit level interconnections between the various functional blocks shown in FIG. The host device emulator 102 is described in more detail with particular reference to FIGS.

  As described above, the host device emulator 102 simulates a connection between a blood glucose measurement engine and a host device into which the blood glucose measurement engine is incorporated or otherwise connected. In the embodiment shown in FIG. 1, the host device emulator 102 includes a measurement engine port 110 to which a blood glucose measurement engine (not shown) can be communicatively connected. Measurement engine port 110 typically includes a printed circuit board (PCB) connector to which a blood glucose measurement engine can be communicatively connected, as described in more detail herein. However, it should be understood that other similar connectors can be used without limitation, including wired or wireless connections. In the embodiment of the measurement engine port 110 shown in FIG. 2, the measurement engine port 110 is a printed circuit such as a surface mount connector DF17 (2.0) -30DP-0.5V (57) manufactured by Hirose Electric Co., Ltd. A board connector 112 is included. The connector 112 can be used to receive a blood glucose measurement engine printed circuit board such that the blood glucose measurement engine is mechanically and communicatively connected to the host device emulator 102. Connector 112 also facilitates communicatively connecting the blood glucose measurement engine to various other elements of host device emulator 102 described in more detail herein.

  As described above, measurement engine port 110 is communicatively connected to communication port 130, which may also be communicatively connected to diagnostic computer 180. In the embodiment of communication port 130 shown in FIG. 3, communication port 130 is used to convert electrical input signals received from the blood glucose measurement engine into standardized serial communication signals that can be processed by diagnostic computer 180. It includes a wired RS232 interface 132 that can be used. For example, the RS232 interface 132 may include an RS232 compatible transceiver, MAX3318E, manufactured by Maxim Integrated Products, as shown in FIG. The RS232 transceiver is communicatively connected to the printed circuit board connector 112 of the measurement engine port 110 as shown in FIGS. In the embodiment of the RS232 interface 132 shown in FIG. 3, a pair of 9-pin connectors from Norcomp, DB9 female type, such as NORCOM 182-2-009-213R531, to facilitate connection of the RS232 interface to the diagnostic computer 180. Connectors 134, 136 are connected to the RS232 interface.

  Although FIG. 3 shows a wired RS232 interface 132, it should be understood that in other embodiments, the interface may be wireless. For example, an RF transceiver, IR transceiver or similar wireless communication device can be used to communicatively connect the measurement engine port 110 to the diagnostic computer 180.

  Still referring to FIGS. 1-10, control is provided between a host device (not shown) communicatively connected to host device port 190 and a blood glucose measurement engine communicatively connected to measurement engine port 110. Host device port 190 is communicatively connected to measurement engine port 110 so that signals and / or data signals can be exchanged. Host device port 190 typically includes a printed circuit board (PCB) connector to which the host device can be communicatively connected. For example, in the embodiment of the host device port 190 shown in FIG. 9, the host device port 190 is a surface mount connector manufactured by Hirose Electric Co., Ltd., such as DF17 (4.0) -30DS-0.5V (57). A printed circuit board connector 192 is included. In this embodiment, the printed circuit board of the host device may be removably inserted into the printed circuit board connector 192 so that the host device is mechanically and communicably connected to the host device emulator 102. However, it should be understood that other similar connectors may be used, including without limitation wired or wireless connectors.

  In the embodiment described herein, the host device port 190 is also communicatively connected to the communication port 130 as shown in FIGS. Accordingly, the communication port 130 and the host device port 190 are control signals and / or data between the host device communicatively connected to the host device port 190 and the diagnostic computer 180 communicatively connected to the communication port 130. It should be understood that it facilitates the exchange of electrical signals such as signals. Further, the host device port 190, the measurement engine port 110, and the communication port 130 are between the host device communicatively connected to the host device port 190 and the blood glucose measurement engine communicatively connected to the measurement engine port 110. It should also be understood that it facilitates the use of the diagnostic computer 180 connected to the communication port 130 to monitor electronic signals exchanged on the computer.

  At least one indicator 160 is electrically connected to the measurement engine port 110. In one embodiment, the at least one indicator 160 is communicated between a diagnostic computer 180 communicatively connected to the communication port 130 and a blood glucose measurement engine communicatively connected to the measurement engine port 110. Providing a visible and / or audible signal indicative of the signal. Further, the at least one indicator may provide a visibility and / or audible indication of the status of the blood glucose measurement engine that is communicatively connected to the measurement engine port 110. For example, at least one indicator may indicate that the blood glucose measurement engine is “ready” or that the blood glucose measurement engine is processing a test sample and is transmitting and receiving data (ie, “way” “King”) may provide an indication that the blood glucose measurement engine is “working”, such as when on the way and / or receiving instructions from the diagnostic computer. The at least one indicator may also provide a visual indication that power is being supplied to the host device emulator 102.

  In the host device emulator embodiment described herein, the host device emulator includes four visual indicators, in particular, light emitting diodes (LEDs) included in the two indicator circuits 165, 166 shown in FIG. ) Is included. The first indicator circuit 165 includes an orange LED 161 and a green LED 162. Each LED 161, 162 is electrically connected to a logic inverter 167 such as a Schmitt trigger input tiny logic UHS inverter, NC7NZ14K8X, manufactured by Fairchild Semiconductor. The orange LED 161 is electrically connected to the measurement engine port 110 and the host device port 190 as shown in FIGS. 2, 8 and 9 and is also communicatively connected to the measurement engine port 110. And a host device that is communicatively coupled to host device port 190 can be used to provide a visual indication of electrical signals (ie, measurement engine request signals) exchanged. For example, the orange LED 161 may blink and / or remain lit when an electrical signal is exchanged and extinguish when the electrical signal is not exchanged.

  The green LED 162 is electrically connected to the measurement engine port 110 and the host device port 190 as shown in FIGS. 2, 8 and 9 and is also communicatively connected to the measurement engine port 110. Can be used to provide a visual display of the status of the. For example, when the blood glucose measurement engine is ready to receive instructions from the host device and / or diagnostic computer, or is ready to send data (ie, a measurement engine ready signal) to the host device and / or diagnostic computer. The green LED 162 is lit when the blood glucose measurement engine is “ready”, such as when it is ready. However, the blood glucose measurement engine, for example, when the blood glucose measurement engine is performing a blood glucose test, transmitting and receiving data, and / or receiving instructions from a host device or diagnostic computer Is “working”, the green LED 162 is off.

  The second indicator circuit 166 includes two red LEDs 163 and 164. The first red LED 163 is electrically connected to a logic inverter 167 such as a Schmitt trigger input tiny logic UHS inverter, NC7NZ14K8X, manufactured by Fairchild Semiconductor. The first red LED 163 is also electrically connected to the measurement engine port 110 and the host device port 190 as shown in FIGS. 2, 8 and 9, and can communicate from the wake request circuit 140 to the measurement engine port 110. Can be used to provide a visual indication of the wake request signal sent to the blood glucose measurement engine connected to the. The second red LED 164 is electrically connected to the power source 120 (further discussed in this document) and is lit when power is supplied to the host device emulator 102.

  Although the LEDs shown in FIG. 8 are shown herein as orange, green or red, the LEDs may be any suitable color as long as they provide a visual indication of a particular event. Should be understood.

  Still referring to the embodiment of the host device emulator 102 shown in FIGS. 1-10, the host device emulator 102 may include a power supply 120. The power source 120 may be electrically connected to the measurement engine port 110, the communication port 130, and the at least one indicator 160 so that the power from the power source 120 is supplied to the respective components. In the embodiment described herein, the power supply 120 and the measurement engine port 110 are configured such that when the blood glucose measurement engine is communicatively connected to the measurement engine port 110, the power supply 120 can measure blood glucose through the measurement engine port 110. By providing power to the engine, the host device emulator 102 is configured to more closely emulate the attachment of the blood glucose measurement engine to the host device.

  In the embodiment of power supply 120 shown in FIG. 4, the power supply includes a power regulator 122, a rectifier circuit 123, and a DC power jack 124 in addition to various electronic components (eg, resistors and capacitors) that perform signal conditioning. Yes. For example, in the embodiment of the power supply 120 shown in FIG. 4, the power regulator 122 is a 500 mA, low noise, LDO micropower regulator, LT1763 manufactured by Linear Technology, and the electrical input is a DC power supply manufactured by CUI. Brought through Jack, PJ-202A. With these components, the power supply 120 can be used to convert a 5 volt electrical input into a 3.1 VCC output signal that powers various components of the host device emulator 102.

  In addition to communication port 130, measurement engine port 110, power supply 120, and at least one indicator 160, host device emulator 102 also includes programming port 170, wake request circuit 140, expansion port 195, and reset circuit 150. Also good. For example, the programming port 170 may be connected to the measurement engine port 110 such that when the blood glucose measurement engine is communicatively connected to the measurement engine port 110, the programming port 170 may be communicatively connected to the blood glucose measurement engine. Can be communicatively connected to the host device port 190 and the power supply 120. The programming port 170 also allows the computer readable instructions to be downloaded from the computer through the programming port 170 and the measurement engine port 110 and recorded directly in the associated memory to operate on the blood glucose measurement engine. (Not shown) can be communicably connected. The use of a separate programming port facilitates rapid programming and reprogramming of the blood glucose measurement engine as it facilitates fast transfer of computer readable instructions directly to the blood glucose measurement engine . In the embodiment of programming port 170 shown in FIG. 7, the programming port includes a connector 172, such as a 4 walled header connector, 2514-6002UB, manufactured by 3M Interconnect Solutions Division. Connector 172 may be communicatively connected to measurement engine port 110 and host device port 190 as shown in FIGS.

  In another embodiment (not shown), programming port 170 may include a processor that is communicatively coupled to a memory that stores computer-readable and executable instructions. The processor may be used to upload instructions to a blood glucose measurement engine communicatively connected to the measurement engine port 110, thereby programming or reprogramming the blood glucose measurement engine.

  The reset circuit 150 is communicatively connected to the measurement engine port 110, the host device port 190, and the power supply 120, and when the blood glucose measurement engine is communicatively connected to the measurement engine port 110, the blood glucose measurement engine. Promote the provision of reset signals to The reset signal resets or restarts the blood glucose measurement engine that is communicatively connected to the measurement engine port 110. In the embodiment of the reset circuit 150 shown in FIG. 5, the reset circuit 150 includes a manual reset switch 154 connected to the supervisory reset circuit 152. For example, the switch may include a switch made by Panasonic ECG, EVQPLHA14, and the monitoring integrated circuit is a nanopower monitoring circuit with manual reset, MAX6863, made by Maxim Integrated Products. Manual reset switch 154 and supervisory reset circuit 152 are electrically connected to measurement engine port 110, host device port 190, and power supply 120 as shown in FIGS.

  The wake request circuit 140 is communicatively connected to the measurement engine port 110 and the power source 120 and outputs a wake request signal to the blood glucose when the blood glucose measurement engine is mechanically and electrically connected to the measurement engine port 110. Promote the provision to the measurement engine. The wake request signal causes the blood glucose measurement engine processor to wake up from a “standby” or “sleep” mode so that the blood glucose measurement engine is ready to receive instructions from the diagnostic computer and / or host device. The wake request circuit 140 includes a manual switch for generating a wake request signal to the blood glucose measurement engine. For example, wake request switch 142 is electrically connected to measurement engine port 110 and host device port 190 as shown in FIGS. The wake request switch 142 may include a switch manufactured by Panasonic ECG, EVQPLHA14.

  In the embodiment of system 100 shown in FIG. 1, host device emulator 102 includes an expansion port 195. The extension port 195 is communicably connected to the measurement engine port 110. The same applies to the host device port 190, and the expansion port 195 can be communicably connected to the host device. Accordingly, the expansion port 195 is a control signal and / or data signal between the host device communicatively connected to the expansion port 195 and the blood glucose measurement engine communicatively connected to the measurement engine port 110. It should be understood that it facilitates the transmission of electrical signals such as The expansion port 195 also facilitates connecting host devices having different interface structures and / or connectors to the host device emulator board, thereby providing a blood glucose measurement engine designed to be incorporated into different host devices. It should be understood that it provides flexibility in the examination of In the embodiment of expansion port 195 shown in FIG. 10, the expansion port includes a connector 196 such as a 4 walled header connector, 2510-6002UB, manufactured by 3M Interconnect Solutions Division. The expansion port 195 may be communicably and electrically connected to the power source 120, the measurement engine port 110, and the host device port 190, as shown in FIGS.

  In the embodiment of the host device emulator 102 shown in FIG. 1, the host device emulator 102 includes a host device port 190 to which the host device can be communicatively connected. However, it should be understood that in other embodiments (not shown), the host device emulator 102 may be configured without a host device port. In these embodiments, the diagnostic computer 180 communicatively connected to the communication port 130 is programmed to function as a host device, and in addition to any diagnostic or test functions, the diagnostic computer is connected to the measurement engine port 110. Control signals and / or exchange of data to a blood glucose measurement engine communicatively coupled to the host device, thereby simulating the function of the host device.

  While the host device emulator 102 shown in FIG. 1 includes a wake request circuit 140, a programming port 170, a reset circuit 150, and an expansion port 195, other embodiments of the host device emulator may include one of these elements or It should be understood that it may be configured without having more. For example, it should be understood that the host device emulator may be configured without the expansion port 195 or without the programming port 170. Alternatively or in addition, the host device emulator may be configured without a wake request circuit or reset circuit.

  Referring now to FIGS. 11-14, the host device emulator 102 described herein is a printed circuit board (PCB) 104 having appropriate conductive paths to facilitate the desired interconnection of components. Above, it can be constructed by arranging the various parts shown in FIGS. For example, FIG. 11 shows one embodiment of the top surface of the host device emulator 102 showing the relative layout of the various electronic components shown in FIGS. As shown in FIG. 11, the host device port 190, along with various electronic components including a communication port, a power supply, at least one indicator, a wake request circuit, a programming port, an expansion port, and a reset circuit, Arranged on the top surface. FIG. 12 shows a component layout on the lower surface of the host device emulator 102 when viewed from the upper surface of the host device emulator 102. As shown in FIG. 12, the measurement engine port 110 is located on the lower surface of the host device emulator 102 just opposite the host device port 190. This arrangement facilitates direct connection of the host device port 190 to the measurement engine port 110. FIGS. 13 and 14 show the conductive paths on the top and bottom surfaces of the PCB 104 shown in FIGS. 11 and 12, respectively.

  11-14 illustrate one exemplary embodiment of the respective components utilized to configure the PCB 104 and the host device emulator 102, but configure the host device emulator 102 with the desired functionality. It should be understood that other component placement directions and / or layouts are possible.

  The operation of the system 100 for testing the blood glucose measurement engine will now be described with particular reference to FIGS. In one embodiment, testing of a blood glucose measurement engine using the system 100 shown in FIG. 1 is performed by connecting the blood glucose measurement engine to a host device emulator mechanically, electrically, and communicatively. As described above, connecting the blood glucose measurement engine to the measurement engine port 110 on the lower surface of the host device emulator 102 by inserting the printed circuit board of the blood glucose measurement engine into the PCB connector 112 of the measurement engine port 110. Including. The host device emulator 102 is also connected to the diagnostic computer 180 via the communication port 130 and the DB9 female connector 134.

  In this embodiment, the host device is not connected to the host device emulator so that the diagnostic computer 180 provides diagnostic and control signals to the measurement engine via the diagnostic tool and the host device emulator 102, It should be understood that it functions as any simulated host device that receives data signals from the blood glucose measurement engine via the host device emulator 102.

  When the blood glucose measurement engine is connected to the host device emulator 102, power is supplied from the power source 120 to the blood glucose measurement engine via the measurement engine port 110, and the activation indicator (ie, the second red LED 164) is turned on. Light up. Thereafter, the wake request switch 142 may be activated, which causes a wake request signal to be sent to the blood glucose measurement engine via the measurement engine port 110. When the wake request signal is sent, the wake request indicator (ie, the first red LED 163) is lit and the blood glucose measurement engine is started.

  When the blood glucose measurement engine is activated, the measurement engine ready indicator (ie, green LED 162) is lit, indicating that the blood glucose measurement engine is ready to receive instructions from the diagnostic computer 180. . At this point, the diagnostic computer will run a diagnostic program to test the availability and functionality of the blood glucose measurement engine, and analyze and qualify (ie, glucose test using the blood glucose measurement engine). Query the measurement engine for test data stored for determining whether the glucose measurement for the standard meets the reference value, or stored in the associated memory to act on the blood glucose measurement engine Can be used to update and / or modify a set of programmed instructions.

  For example, in one embodiment, the diagnostic computer acts as a host device and tests blood glucose measurements by sending control signals to the blood glucose measurement engine via communication port 130 and measurement engine port 110. Start. When the test is started, the operator inserts a test strip into the blood glucose measurement engine. At this time, the blood glucose measurement engine inspects the strip to confirm that the test strip is valid. When the test strip is confirmed, the blood glucose measurement engine sends a measurement engine request signal to the diagnostic computer via the measurement engine port 110 and the communication port 130, causing the measurement engine request indicator (ie, the orange LED 161) to light up. . The measurement engine request signal to the diagnostic computer 180 indicates that the blood glucose measurement engine is ready to make a blood glucose measurement. The diagnostic computer 180 then sends a control signal to the blood glucose measurement engine via the communication port 130 and the measurement engine port 110 to instruct the blood glucose measurement engine to perform glucose measurement. The measurement engine demand indicator is lit when a control signal is sent to the blood glucose measurement engine. While these various signals are exchanged between the blood glucose measurement engine and the diagnostic computer 180, the diagnostic computer monitors the signals, and in one embodiment, the blood glucose measurement engine for subsequent analysis. The signal received from is recorded in the memory.

  When the blood glucose measurement engine receives a control signal from the diagnostic computer 180, the blood glucose measurement engine makes a glucose measurement on the test strip. During the test, the measurement engine ready indicator is off, indicating that the blood glucose measurement engine is “working” and cannot receive any further control signals from the diagnostic computer. However, the diagnostic computer 180 can be used to monitor each step of the measurement process via the host device emulator 102. For example, the diagnostic computer 180 advances the blood glucose measurement engine one step at a time through each instruction of the glucose measurement process, and pauses the blood glucose measurement engine after each instruction of the measurement process is performed. It can be used to control a blood glucose measurement engine during the glucose measurement process. In this way, the diagnostic computer can be used to ensure that each step of the glucose measurement process is properly performed by the glucose measurement engine.

  When the glucose measurement is performed, the measurement engine ready indicator is turned on, the measurement engine request signal indicating that the glucose measurement is completed and the test data is prepared is transmitted to the measurement engine port 110 of the host device emulator 102 and the communication. This is communicated to diagnostic computer 180 via port 130. The measurement engine request indicator is lit when a measurement engine request signal is communicated to the diagnostic computer 180. The blood glucose measurement engine then communicates test data values and error signals to the diagnostic computer 180 for analysis and qualification. When test data and an error signal are received from the blood glucose measurement engine, the diagnostic computer 180 sends a control signal to the blood glucose measurement engine telling it to shut down the engine.

  Thereafter, the data obtained from the glucose measurement on the standardized glucose solution can be analyzed to qualify the measurement and / or to calibrate the blood glucose measurement engine. Also, the performance of the blood glucose measurement engine through the glucose measurement may vary from the blood glucose measurement engine received from the blood glucose measurement engine and / or monitored using the diagnostic computer 180 during the glucose measurement. It should be understood that it may be evaluated to determine whether it functioned properly based on the correct signal. Accordingly, the system 100 can be used to test the functionality of a blood glucose measurement engine while at the same time qualifying and / or calibrating the blood glucose engine in the context of a standardized glucose solution. It should be understood that it can also be used to

  It should also be understood that the functionality and status of the blood glucose measurement engine can be assessed visually by the operator by monitoring various indicators during operation of the blood glucose measurement engine. For example, the indicator may determine whether the blood glucose measurement engine is ready to send or receive an electronic signal at an appropriate time, whether the blood glucose measurement engine has stopped during operation, and / or blood glucose It may be used to determine if the measurement engine is sending and receiving electronic signals at the appropriate time. If the blood glucose measurement engine does not function properly during operation, the operator can manually reset the blood glucose measurement engine using the reset circuit 150. Thereafter, the cause of the malfunction can be diagnosed by the diagnostic computer 180 by evaluating electronic signals that are transmitted to the blood glucose measurement engine and received from the blood glucose measurement engine during operation.

  In another embodiment, the host device inserts the host device into the PCB connector 192 of the host device port 190 such that the host device is mechanically, electrically, and communicably connected to the host device emulator. Thus, the host device emulator is communicably connected. In this embodiment, the host device emulator 102 is also connected to the diagnostic computer 180 via the communication port 130 via the DB9 female connector 136, which connection monitors signals to and from the host device. Used for. The host device then initiates glucose measurement using the blood glucose measurement engine while the diagnostic computer 180 is monitoring control signals and data signals exchanged between the blood glucose measurement engine and the host device. Used to do. Once the glucose measurement is complete, test data can be downloaded from the blood glucose measurement engine to the diagnostic computer and analyzed to qualify and / or calibrate the blood glucose measurement engine. Also, the functionality of the blood glucose measurement engine may be evaluated based on signals exchanged between the blood glucose measurement engine and the host device during glucose measurement.

  In any of the above-described methods using the system 100 to test the functionality of a blood glucose measurement engine, the diagnostic computer 180 uses the individual functions and / or process steps performed by the blood glucose measurement engine. It may be used to provide diagnostic signals to the blood glucose measurement engine via the communication port and the measurement engine port for the purpose of assessing possibilities. Further, the diagnostic computer 180 may be used to calibrate or recalibrate the blood glucose measurement engine based on test data obtained from glucose measurements made on standardized glucose solutions.

  It should further be appreciated that the system 100 may be used to test the functionality of a blood glucose measurement engine under controlled laboratory conditions. For example, the system 100 may be used in a blood glucose measurement engine durability test to ensure consistency of test data for multiple glucose measurements. Similarly, the system 100 may be used to test a blood glucose measurement engine under conditions with different environmental conditions such as temperature and / or humidity.

  Although a method of using the system 100 to test a blood glucose measurement engine and / or qualify data obtained from the blood glucose measurement engine is described herein, the system 100 and / or host device It should be understood that the emulator 102 can be used for other purposes. For example, in one embodiment, the host device emulator 102 may be used in the manufacture of a blood glucose measurement engine to facilitate programming of the blood glucose measurement engine. In this embodiment, the host device emulator 102 can be connected to a newly manufactured blood glucose measurement engine via the measurement engine port 110. The programming port 170 may be communicatively connected to a computer or processor that can be used to download computer readable and executable instructions to the blood glucose measurement engine. Thus, it should be understood that the host device emulator 102 can be used to program a blood glucose measurement engine.

  While specific embodiments have been shown and described herein, it will be understood that various other changes and modifications may be practiced without departing from the spirit and scope of the claimed subject matter. Should be. Further, although various aspects of the claimed subject matter are described herein, it should be understood that such aspects need not be used in combination. Accordingly, the appended claims are intended to cover changes and modifications that fall within the scope of the invention-specific matter recited in the claims.

The following is a list of preferred embodiments of the present invention.
1. A host device emulator 102 including a measurement engine port 110 communicatively connected to a communication port 130 and electrically connected to a power source 120; and
Testing a blood glucose measurement engine communicatively connected to the communication port 130 of the host device emulator 102 and including a processor and a diagnostic computer 180 including a memory with computer readable and executable instructions A system 100 for
A data signal, a control signal between the diagnostic computer 180 and the blood glucose measurement engine when the host device emulator 102 is communicatively connected to the measurement engine port 110; And simulate the connection with the host device by facilitating the communication of diagnostic signals,
The processor is
To send control signals and diagnostic signals to the blood glucose measurement engine,
To receive and analyze data signals transmitted from the blood glucose measurement engine; and
In order to monitor the glucose measurement process performed by the blood glucose measurement engine,
A system for testing a blood glucose measurement engine that executes instructions that the computer can read and execute.
2. The host device emulator 102 further includes a host device port 190 communicatively connected to the measurement engine port 110, the communication port 130, and the power source 120;
Instructions readable and executable by the computer between the blood glucose measurement engine communicatively connected to the measurement engine port 110 and the host device communicatively connected to the host device port 190 The system of embodiment 1 executed by the processor to monitor exchanged data signals and control signals.
3. Instructions readable and executable by the computer advance the blood glucose measurement engine step by step through the glucose measurement process, and pause the blood glucose measurement engine after one instruction of the glucose measurement process is executed The system of embodiment 1 executed by the processor to do so.
4). The system of embodiment 1, wherein the computer readable and executable instructions are executed by the processor to calibrate the blood glucose measurement engine.
5. A wake request indicator 163, a measurement engine request indicator 161, and a measurement engine ready indicator 162;
The wake request indicator 163 is electrically connected to the measurement engine port 110 and provides a visibility or audible signal when a wake request signal is transmitted to the measurement engine port 110;
The measurement engine request indicator 161 is electrically connected to the measurement engine port 110 and is visible or audible when an electronic signal is transmitted to or from the measurement engine port 110. Providing a signal of, and
The measurement engine ready indicator 162 is electrically connected to the measurement engine port 110, the blood glucose measurement engine is communicatively connected to the measurement engine port 110, and the blood glucose measurement engine is controlled. The system of embodiment 1, wherein the system provides a visible or audible signal when ready to receive a signal or transmit a data signal.
6). The system of embodiment 1, wherein the communication port 130 of the host device emulator 102 includes an RS232 interface.
7). The system of embodiment 1 wherein the host device emulator 102 includes a reset circuit 150 communicatively connected to the measurement engine port 110.
8). The system of embodiment 7, wherein the reset circuit 150 includes a manual reset switch 154.
9. The system of embodiment 1 wherein the host device emulator includes a wake request circuit 140 communicatively connected to the measurement engine port 110.
10. The system of embodiment 9 wherein the wake request circuit 140 includes a manual wake request switch 142.
11. The system of embodiment 1 wherein the host device emulator includes a programming port 170 communicatively connected to the measurement engine port 110.
12 The programming port 170 includes a processor communicatively connected to a memory having computer readable and executable instructions stored therein, the processor communicatively connected to the measurement engine port 110. 12. The system of embodiment 11 that can be used to execute said instructions to upload a set of instructions to a medium glucose measurement engine.
13. The system of embodiment 1 wherein the host device emulator 102 further includes an expansion port 195 communicatively connected to the measurement engine port 110.
14 The system of embodiment 1, wherein the blood glucose measurement engine is powered by the power source 120 when the blood glucose measurement engine is connected to the measurement engine port 110.
15. 3. The system of embodiment 2 wherein the host device is powered by the power source 120 when the host device is connected to the host device port 190.
16. A host device emulator for facilitating communication between a blood glucose measurement engine and a diagnostic computer 180, comprising:
A power source 120;
A communication port 130 electrically connected to the power source 120 and communicably connected to the diagnostic computer 180;
A measurement engine port 110 communicatively connected to the communication port 130 and electrically connected to at least one indicator 160 and the power source 120, wherein the measurement engine port 110 communicates with the blood glucose measurement engine Can be connected,
A host device port 190 electrically connected to the power supply 120 and communicatively connected to the measurement engine port 110 and the communication port 130, wherein the host device port 190 can be communicatively connected to the host device. ,
And
The measurement engine port 110, the host device port 190, and the communication port 130 are:
To facilitate communication of data signals, control signals, and diagnostic signals between the diagnostic computer 180 and the blood glucose measurement engine,
To facilitate communication of data and control signals between the host device and the blood glucose measurement engine; and
To facilitate use of the diagnostic computer 180 to monitor data and control signals between the host device and the blood glucose measurement engine,
A host device emulator 102 that can be used.
17. At least one of the indicators 160 includes a wake request indicator 163, a measurement engine request indicator 161, and a measurement engine ready indicator 162;
The wake request indicator 163 is electrically connected to the measurement engine port 110 and provides a visibility or audible signal when a wake request signal is transmitted to the measurement engine port 110;
The measurement engine request indicator 161 is electrically connected to the measurement engine port 110 and is visible or audible when an electronic signal is transmitted to or from the measurement engine port 110. Providing a signal of, and
The measurement engine ready indicator 162 is electrically connected to the measurement engine port 110, the blood glucose measurement engine is communicatively connected to the measurement engine port 110, and the blood glucose measurement engine is controlled. 17. The host device emulator 102 of embodiment 16 that provides a visible or audible signal when it is ready to receive a signal or transmit a data signal.
18. Embodiment 17 The host device emulator 102 of embodiment 16, wherein the communication port 130 includes an RS232 interface.
19. It further includes a reset circuit 150 communicatively connected to the measurement engine port 110 and a wake request circuit 140 communicatively connected to the measurement engine port 110, wherein the reset circuit 150 includes the measurement engine port 110. An implementation including a reset switch 154 for manually initiating a reset signal to 110, and wherein the reset circuit 140 includes a wake request switch 142 for manually initiating a wake request signal to the measurement engine port 110. The host device emulator of form 16.
20. 17. The host device emulator 102 of embodiment 16 further comprising a programming port 170 communicatively connected to the measurement engine port 110.

Claims (21)

A system (100) for testing a modular blood glucose measurement engine that can be incorporated into or connected to a portable host device comprising:
A host device emulator (102) communicatively connected to the communication port (130) and including a measurement engine port (110) electrically connected to a power source (120); and
A diagnostic computer (180) communicatively connected to the communication port (130) of the host device emulator (102) and including a processor and a memory with computer readable and executable instructions;
When the host device emulator (102) is communicatively connected to the measurement engine port (110), the diagnostic computer (180) and the modular blood glucose measurement engine Simulating a connection with the portable host device to which the modular blood glucose measurement engine can be operably connected by facilitating communication of data signals, control signals, and diagnostic signals to and from the
The diagnostic computer is configured to control operation of the modular blood glucose measurement engine by providing a control signal to the modular blood glucose measurement engine;
The processor is
To send the control signal and diagnostic signal to the modular blood glucose measurement engine and initiate blood glucose measurement by the modular blood glucose measurement engine,
In order to receive and analyze data signals transmitted from the modular blood glucose measurement engine,
To monitor the glucose measurement process performed by the modular blood glucose measurement engine,
Sending a control signal to the modular blood glucose measurement engine to shut down the modular blood glucose measurement engine; and
To evaluate the functionality of the modular blood glucose measurement engine based on the received data signal or the monitored glucose measurement process,
A system for testing a modular blood glucose measurement engine that executes instructions that the computer can read and execute. The host device emulator (102) further includes a host device port (190) communicatively connected to the measurement engine port (110), the communication port (130), and the power source (120);
Instructions readable and executable by the computer are communicatively connected to the modular blood glucose measurement engine communicatively connected to the measurement engine port (110) and to the host device port (190). The system of claim 1 executed by the processor to monitor data and control signals exchanged with a portable host device. Instructions readable and executable by the computer advance the modular blood glucose measurement engine step by step through the glucose measurement process, and the modular blood glucose measurement after one instruction of the glucose measurement process is executed The system of claim 1, executed by the processor to suspend an engine. The system of claim 1, wherein the computer readable and executable instructions are executed by the processor to calibrate the modular blood glucose measurement engine. A wake request indicator (163), a measurement engine request indicator (161), and a measurement engine ready indicator (162);
The wake request indicator (163) is electrically connected to the measurement engine port (110), and a visibility or audible signal is transmitted when a wake request signal is transmitted to the measurement engine port (110). Provide
The measurement engine request indicator (161) is electrically connected to the measurement engine port (110) and when an electronic signal is transmitted to or from the measurement engine port (110). Provide a visible or audible signal, and
The measurement engine ready indicator (162) is electrically connected to the measurement engine port (110), the modular blood glucose measurement engine is communicatively connected to the measurement engine port (110), and The system of claim 1, wherein the modular blood glucose measurement engine provides a visible or audible signal when it is ready to receive a control signal or transmit a data signal. The system of claim 1, wherein the host device emulator (102) includes a reset circuit (150) communicatively coupled to the measurement engine port (110). The system of claim 1, wherein the host device emulator (102) includes a wake request circuit (140) communicatively coupled to the measurement engine port (110). The system of claim 1, wherein the host device emulator (102) includes a programming port (170) communicatively connected to the measurement engine port (110). The programming port (170) includes a processor communicatively coupled to a memory having computer readable and executable instructions stored therein, the processor being communicatively coupled to the measurement engine port (110). 9. The system of claim 8, wherein the system can be used to execute a command to upload the command set to the modular blood glucose measurement engine. The system of claim 1, wherein the host device emulator (102) further includes an expansion port (195) communicatively connected to the measurement engine port (110). The system of claim 1, wherein the modular blood glucose measurement engine is powered by the power source (120) when the modular blood glucose measurement engine is connected to the measurement engine port (110). . Wherein when the portable host device is connected the host device port (190), the portable host device, according to claim 2, wherein the supplied power by said power source (120) system. A modular blood glucose measurement engine that can be incorporated in or connected to a portable host device and the modular blood glucose measurement engine by supplying control signals to the modular blood glucose measurement engine A host device emulator (102) that facilitates communication with a controlling diagnostic computer (180), comprising:
A power source (120);
A communication port (130) electrically connected to the power source (120) and communicatively connectable to the diagnostic computer (180);
A measurement engine port (110) communicatively connected to the communication port (130) and electrically connected to at least one indicator (160) and the power source (120), wherein the measurement engine port (110) ) Can be communicably connected to the modular blood glucose measurement engine,
A host device port (190) electrically connected to the power source (120) and communicatively connected to the measurement engine port (110) and the communication port (130), wherein the host device port (190) Can be communicably connected to the portable host device,
And
The measurement engine port (110), the host device port (190), and the communication port (130);
Data signal between the diagnostic computer (180) and the modular blood glucose measuring engine, a signal for starting blood glucose measurement by the modular blood glucose measuring engine and the modular blood glucose measuring engine In order to facilitate communication of control signals, including diagnostic signals, and diagnostic signals
To facilitate communication of data and control signals between the portable host device and the modular blood glucose measurement engine,
To facilitate the use of the diagnostic computer (180) to monitor data and control signals between the portable host device and the modular blood glucose measurement engine; and
To facilitate the use of the diagnostic computer (180) to evaluate the functionality of the modular blood glucose measurement engine based on the received data signal or monitored glucose measurement process
A host device emulator (102) that can be used. At least one of the indicators (160) includes a wake request indicator (163), a measurement engine request indicator (161), and a measurement engine ready indicator (162);
The wake request indicator (163) is electrically connected to the measurement engine port (110), and a visibility or audible signal is transmitted when a wake request signal is transmitted to the measurement engine port (110). Provide
The measurement engine request indicator (161) is electrically connected to the measurement engine port (110) and when an electronic signal is transmitted to or from the measurement engine port (110). Provide a visible or audible signal, and
The measurement engine ready indicator (162) is electrically connected to the measurement engine port (110), the modular blood glucose measurement engine is communicatively connected to the measurement engine port (110), and The host device emulator (102) of claim 13, wherein the modular blood glucose measurement engine provides a visible or audible signal when ready to receive a control signal or to transmit a data signal. . A reset circuit (150) communicatively connected to the measurement engine port (110); and a wake request circuit (140) communicatively connected to the measurement engine port (110). Circuit (150) includes a reset switch (154) for manually generating a reset signal to said measurement engine port (110);
14. The host device emulator (102) of claim 13, wherein the wake request circuit (140) includes a wake request switch (142) for manually triggering a wake request signal to the measurement engine port (110). The host device emulator (102) of claim 13, further comprising a programming port (170) communicatively coupled to the measurement engine port (110). Evaluating the functionality of the modular blood glucose measurement engine;
(I) executing a diagnostic program based on the received data signal to test the usability and functionality of the modular blood glucose measurement engine;
(Ii) analyzing the received data signal to qualify the modular blood glucose measurement engine, and (iii) received to calibrate the modular blood glucose measurement engine The system (100) of any preceding claim, comprising at least one of analyzing the data signal. Instructions readable and executable by the computer are located in a measurement engine memory associated with the modular blood glucose measurement engine operatively based on the evaluation of the functionality of the modular blood glucose measurement engine. The system (100) of claim 17, wherein the system (100) is executed by the processor to change an instruction. The modular blood glucose measurement based on the data signal and the control signal exchanged between the modular blood glucose measurement engine and the portable host device wherein the computer readable and executable instructions are The system (100) of claim 2, wherein the system (100) is executed by the processor to evaluate the functionality of an engine. Facilitating the use of the diagnostic computer (180) to evaluate the functionality of the modular blood glucose measurement engine;
(I) executing a diagnostic program based on the received data signal to test the usability and functionality of the modular blood glucose measurement engine;
(Ii) analyzing the received data signal to qualify the modular blood glucose measurement engine;
(Iii) analyzing the received data signal to calibrate the modular blood glucose measurement engine; and
14. The host device of claim 13, comprising (iv) analyzing at least one of the data signal and the control signal exchanged between the modular blood glucose measurement engine and the portable host device. Emulator (102). The measurement engine port (110), the host device port (190), and the communication port (130) are configured to measure the modular blood glucose based on an evaluation of the functionality of the modular blood glucose measurement engine. The host device emulator (102) of claim 13, wherein the host device emulator (102) can be used to modify instructions located in a measurement engine memory associated with acting on the engine.

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